C-AXIS PR, INC FDA Inspection Record
C-AXIS PR, INC is an FDA-registered facility (FEI 3005029036) located in Caguas, PR, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 24, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 24, 2024 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) |
| Mar 12, 2020 | No Action Indicated (NAI) | No citations listed |
| Feb 19, 2016 | Voluntary Action Indicated (VAI) | Management review - Lack of or inadequate procedures (21 CFR 820.20(c)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) |
Facility details
- Company
- C-Axis PR., Inc.
- Location
- Caguas, PR (US)
- Source
- device